Kornimate/medical-research-clean huggingface dataset:
impact of neurochecks on sleep in critically ill adults

Conditions: Cerebral Aneurysm

Summary: background: following acute brain injury (abi), patients are monitored in the intensive care unit (icu) where providers rely on frequent neurological examinations ("neurochecks") to assess for neurodeterioration. serial neurochecks are part of guideline recommendations, but there is equipoise between hourly (q1) and every-other-hour (q2) evaluation. in the icu, care-related awakenings occur frequently, but it is unclear if differential neurocheck frequencies result in differential sleep, providing the scientific premise for this proposal. population: thirty patients (n=15 per group) who have undergone elective aneurysm coiling will be enrolled. on post-operative day (pod) 0, patients will be screened and approached for informed consent if they do not meet exclusion criteria, e.g., prior intracranial injury, sleep disorders, cognitive impairment, mechanical ventilation. patients with elective aneurysm coiling are being chosen because they require icu level of care following their intracranial procedure, but do not have structural brain injury or ongoing sedation needs that might impact sleep measurements. methods: usual care: patients are monitored every 15-30 minutes for up to 6 hours post-procedure, then q1 or q2 for up to 24 hours. if these patients remain stable, they are discharged home on post-operative day (pod) 1. proposed intervention: enrolled patients will be randomized to q1 or q2 neurochecks following the institutionally required 6 hours of stable neurological and vascular checks. once randomized, patients will undergo placement of electroencephalogram (eeg) with video, electrooculogram, and chin lead. the video eeg will be in place for at least 8 hours to include the overnight (10pm-6am) time period. following completion of the recording, the signals obtained will be reviewed by a blinded polysomnographic sleep technician for sleep characteristics including quantitative assessments of wakefulness, deep (n3) sleep, rem sleep, sleep efficiency, and sleep fragmentation and arousals. on pod1, patients and their nurse will fill out the richards-campbell sleep questionnaire to rate subjective sleep quality.


Eligibility criteria:
inclusion criteria: a. adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm. exclusion criteria: 1. patients with past or current intracranial injury or disease. 2. patients with known flow-limiting pathology of carotid arteries, vertebral arteries, or intracranial arteries. 3. incomplete resolution of aneurysm. 4. known sleep disorders (e.g., insomnia) 5. pregnancy. 6. incarceration. 7. inability to communicate in english 8. cognitive impairment or lack of decision-making capacity. 9. ongoing sedation. 10. mechanical ventilation

Keywords: neurocheck; sleep; neurological examination
synergistic gut-brain axis modulation via vagal stimulation and cognitive behavioral therapy in functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (tavns) + cognitive-behavioral therapy (cbt) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (fd) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in fd clinical outcomes. using a fully non-invasive framework including gastric and brain magnetic resonance imaging (mri) and tavns, the investigators aim to evaluate the potential synergy of tavns and cbt in fd, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements.


Eligibility criteria:
inclusion criteria: age 18-65 years old (inclusive) * ability to give written consent and participate in behavioral intervention in english * willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (tavns) sessions, and engage in homework during treatment * avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session * diagnosis according to the rome iv criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes * stable medical treatment for functional dyspepsia (fd) during 1 month before the study and during the study period exclusion criteria: * previous receipt of cognitive behavioral therapy (cbt) for gastrointestinal symptoms * enteral or parenteral feeding * previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders * estimated glomerular filtration rate (egfr) \< 60 * medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (thc) will be stopped at least 7 days prior to the start of the study and for the duration of the study. however, anti-depressants (ssri's, tca's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the principal investigator whether subjects on anti-depressants will be able to participate in the study * intellectual disability by history * diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy * no active clinical acupuncture therapy * illicit drugs or opioid usage * history of arrhythmias * current pregnancy/breastfeeding * contraindications for magnetic resonance imaging (mri) (implanted ferromagnetic objects, claustrophobia) * weight \> 450 lbs. (limit of the mri table) * allergy to pineapple (used in the test meal during mri) * any other condition interfering with study requirements, according to the investigator
reduction of plantar pressure in neuropathic diabetic foot patients using insoles with removable pegs design

Conditions: Foot Ulcer, Diabetic

Summary: the purpose of this study was to determine if insoles with removable pegs could effectively reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for guidance of peg removal.

the investigators tested the effect of plantar pressure reduction in four conditions: 1. insole of the original shoe 2. peg assist insole but the pegs are not yet removed 3. peg assist insole and the pegs were removed 4. condition3. plus arch support to the insole

Eligibility criteria:
inclusion criteria: * previously diagnosed type 2 diabetes with neuropathic foot were recruited from the outpatient endocrinology and metabolism division of taichung veterans general hospital in central taiwan exclusion criteria: * the exclusion criteria were history of lower extremities amputation, major foot deformities, presence of active plantar foot wound or ulcer, and difficulty walking more than 100 m.

Keywords: offloading plantar pressure insole foot ulcer
intranasal oxytocin in antiosocial personality disorder and psychopathy

Conditions: Antisocial Personality Disorder

Summary: a pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

using a double-blinded, placebo controlled design, we explored similarities and differences in i) an important component of empathic processing (neural response to facial emotional expressions) and ii) decision-making in violent men with aspd+/-psychopathy, compared to healthy non-offenders (no; n= 21 across studies), with placebo and after acute application of intranasal oxytocin, using functional magnetic resonance imaging (fmri).

Eligibility criteria:
inclusion criteria: * male * aged 18-60 * iq greater than 70 as defined by the wechsler abbreviated scale of intelligence (wasi-ii). violent offenders: offenders with convictions for violent crimes (murder, rape, attempted murder, grievous and actual bodily harm) who met dsm-5 criteria for antisocial personality disorder (structured clinical interview for dsm-5 personality disorders (scid-5 pd) psychopathy or non-psychopathy subgroup based on psychopathy checklist- revised (pcl-r; (hare, 2003))- score of 25 as the threshold for psychopathy in this english population. healthy non-offenders: non-offenders with no personality disorder exclusion criteria: * history of major mental disorders (bipolar 1, bipolar 2, major depression or psychotic disorders) * self-reported neurological disorders * head injury resulting in loss of consciousness for 1 hour or longer * severe visual or hearing impairments * contraindications to mri

Keywords: oxytocin; psychopathy; violent offenders; social processing
comparison of botulinum toxin and sphincterotomy in the treatment of chronic anal fissure

Conditions: Pain

Summary: intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.

consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intra-sphincteric injection of botulinum toxin (bt) or lateral internal sphincterotomy (lis). postoperative pain relief, healing of fissure, continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.

Eligibility criteria:
inclusion criteria: * the diagnosis of chronic anal fissure was based on evidence of circumscribed ulcer at anal canal with indurations at the edges and exposure of the horizontal fibers of the internal anal sphincter at its floor. exclusion criteria: * anal fissure that had been operated on before, complicated fissure with cicatricial deformation, large sentinel pile, associated hemorrhoids, suspected inflammatory bowel disease, or malignancy.

Keywords: pain after treatment healing of fissure after treatment continence scores after treatment
web-based approach in nutrition and diabetes

Conditions: Type 2 Diabetes Mellitus; Overweight and Obesity; Nutritional and Metabolic Diseases

Summary: the study aims to test web-based strategies, in overweight or obese participants at risk or affected by type 2 diabetes mellitus , to promote adherence over time to a healthy lifestyle and nutritional medical therapy (tmn). the study population includes 40 subjects, randomly allocated to web group (therapeutic reinforcement through web-based strategies) or traditional group (traditional educational approach). anthropometric and clinical parameters will be collected, as well as scores of validated questionnaires will be administered up to 12 months from the enrollment.


Eligibility criteria:
inclusion criteria: * overweight or obesity (bmi ≥25 kg/m2) * participants with or at risk of type 2 diabetes mellitus * skills in the use web-based technologies and internet accessibility exclusion criteria: * conditions that could interfere with the execution and completion of the project or failure adherence to the protocol.

Keywords: web technologies nutrition
cerebellar rtms theta burst for dual-task walking in parkinson's disease

Conditions: Parkinson; Parkinson Disease; Gait Disorders, Neurologic; Parkinsonism; Gait, Festinating

Summary: objective of the study: to test the efficacy of theta burst cerebellar stimulation on dual task walking in parkinson's disease using a cross-over design and wearing sensors technology design: twenty parkinson's disease patients with no dementia will be recruited for a cross-over sham-controlled study. each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days. each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology .

there are no medical effective treatments for dual-task gait in parkinson's disease. imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for dual-task walking for theta burst repetitive transcranial magnetic stimulation objective of the study: to test the efficacy of theta burst cerebellar stimulation on gait in parkinson's disease using a cross-over design and wearing sensors technology design: parkinson's disease patients able to walk and without dementia/behavioral disturbances will be recruited for a cross-over sham-controlled study. each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days. repetitive cerebellar theta burst stimulation will be performed by duo-mag xt100, using a 3 pulses at 50-hz repeated at a rate of 5-hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. intensity of rtms was set at the 80% of amplitude of motor threshold (rmt) obtained in the left motor cortex for each subject. a sample size of 20 subjects with complete stimulation (2 stimulations per subject, for a total number of stimulation) each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology. sensors assessment: the following gait parameters will be evaluated in normal and cognitive/motor dual-tasks: i) step length ii) step variability iii) step phases iv) turning speed

Eligibility criteria:
inclusion criteria: * established parkinson's disease * ability to stand alone and walk without support exclusion criteria: * dementia or behavioral alterations * contraindication to stimulation

Keywords: repetitive transcranial magnetic stimulation rtms wearing sensors wearables step variability gait variability gait speed dual-task dual-task walking turning
ganaxolone treatment in children with fragile x syndrome

Conditions: Fragile x Syndrome

Summary: this phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, crossover study to investigate ganaxolone treatment in children with fragile x syndrome (fxs). the objective of the study is to assess the safety, tolerability and efficacy of ganaxolone in the treatment of anxiety and attention in subjects with fxs.

this is a single center study conducted at university of california davis (ucd) mind institute. children with fxs between the ages of 6-17 years, inclusive will be randomized at a 1:1 ratio to receive ganaxolone or placebo treatment for 6 weeks, discontinue treatment and washout for 2 weeks, and then cross over to the opposite treatment for another 6 weeks.

Eligibility criteria:
inclusion criteria: * molecular documentation of fmr1 full mutation * ages 6-17 yrs, inclusive * sexually active subjects are required to use a medically acceptable form of birth control exclusion criteria: * non-english or spanish speaking subjects * concomitant systemic steroid, vigabatrin, felbamate and ketoconazole * changes in medications within last 2 months * clinically unstable medical disease, progressive cns disease/disorder * history of recurrent status epilepticus * unwilling to withhold grapefruit or grapefruit juice for the duration of the study * actively suicidal

Keywords: fragile x syndrome ganaxolone anxiety attention pediatric
a study of wf 10 iv solution in patients with advanced hiv disease

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give wf 10 (tcdo) to patients with advanced hiv disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine. this study also examines how tcdo affects the levels of hiv in the body. tcdo is a solution delivered through a vein.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * approved drugs at a stabilized dose except those specifically excluded. * aerosolized pentamidine (300 mg) once a month for pcp prophylaxis. patients must have: * hiv positivity. * absolute cd4 count \< 200 cells/mm3. * intolerance to or refusal to take azt, ddi, ddc, or d4t. * no active opportunistic infection requiring ongoing therapy. * life expectancy at least 3 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * neoplasm other than basal cell carcinoma of the skin. * clinically significant cardiac disease. * anemia. concurrent medication: excluded: * cytotoxic chemotherapy. * corticosteroids. patients with the following prior conditions are excluded: history of myocardial infarction or arrhythmias. prior medication: excluded within 2 weeks prior to study entry: * any antiretroviral agent. * interferon. * systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs. excluded within 30 days prior to study entry: * investigational drugs. prior treatment: excluded within 2 weeks prior to study entry: * radiation therapy. active drug or alcohol abuse.

Keywords: acquired immunodeficiency syndrome antiviral agents
a study of the cost for patients operated for adhesive obstruction (sbo) during a five-year period

Conditions: Adhesive Small Bowel Obstruction

Summary: a cohort study of the cost for patients operated for adhesive small bowel obstruction (sbo) during a five-year period

it is a population-based cohort study of the costs for patients operated for adhesive small bowel obstruction during a five-year period (2007-2012) in two swedish neighboring regions. patients were identified by a broad search of operation and international classification of diseases (icd) codes. data regarding surgery and complications has been analyzed in a previous study (clinical trials no nct0353459) the costs for hospital stay, radiology, intensive care unit (icu)-care, operation for the index sbo care event were calculated. the cost for revisit, sick leave and recurrent sbo during follow-up were calculated. patients were followed to 31st january 2017, last medical note or death.

Eligibility criteria:
inclusion criteria: * above18 years of age * surgery for adhesive surgical bowel obstruction (sbo) exclusion criteria: • surgery for sbo of other etiology than adhesions

Keywords: cohort surgery adhesive small bowel obstruction cost
caffeine, resistance exercise and emg

Conditions: Caffeine

Summary: introduction: several studies have evaluated and confirmed the ergogenic effects of acute caffeine intake on sports performance. however, some studies suggest that this effect predominantly occurs in large muscle groups, potentially due to increased skeletal muscle electrical activity. objectives: this study aims to evaluate the acute effects of caffeine intake on strength, power, muscle endurance, and muscle electrical activity in young adults. it will also analyze the influence of circadian rhythms (morning vs. afternoon) on exercise performance (bench press vs. squat). methods: twelve healthy, physically active participants will be recruited for the study. using a triple-blind, crossover, randomized, and controlled design, participants will ingest either caffeine (3 mg/kg body mass) or a placebo (maltodextrin, 3 mg/kg) 60 minutes before the trial. muscular strength, power, and endurance performance will then be assessed through 1rm tests, and at 25%, 50%, 75%, and 90% of 1rm, along with muscle endurance tests at 65% of 1rm, for both squat and bench press exercises. emg will be used to measure skeletal muscle electrical activity during the tests. the experimental sessions will be conducted in the morning (8:00 am to 10:00 am) and the afternoon (4:30 pm to 6:30 pm).


Eligibility criteria:
inclusion criteria: * age between 18 and 35 years. * body mass index (bmi) \&lt; 25 kg/m². * resistance-trained individuals (more than 2 years of structured training). * healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising. * participants must be able to perform the tests described in the following section. exclusion criteria: * history of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism. * use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study. * sedentary habits (less than 150 minutes/week of moderate exercise). * having undergone prolonged periods of physical inactivity in the 6 months prior to the study. * engaging in strenuous exercise within 48 hours prior to the tests. * failure to replicate the same food intake on both experimental days. * consumption of caffeine or any other stimulant after 6 pm on the day before the tests, to avoid headaches, discomfort, or lethargy in regular caffeine consumers.
safety and efficacy of an artificial tear for the treatment of dry eye

Conditions: Dry Eye Syndrome

Summary: the efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear


Eligibility criteria:
inclusion criteria: * mild, moderate or severe symptoms of dry eye exclusion criteria: * uncontrolled systemic disease * use of systemic medications affecting dry eye * pregnancy or planning a pregnancy * contact lens wear
botswana diarrheal diseases study

Conditions: HIV Infections

Summary: the goals of this study are to: 1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to hiv-infected mothers. * analysis by hiv status of infants, method of feeding, hiv viral loads / cd4 counts of infected mothers. * comparison to rates among infants born to hiv uninfected mothers. 2. link analysis of the functional quality of immunoglobulins in the breast milk of hiv-infected and uninfected mothers.


Eligibility criteria:
inclusion criteria: * subject is able to provide independent informed consent. * subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly. * subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days. for hiv-infected subjects: * mother: hiv antibody is detected by dual hiv-1 elisa and confirmed by western blot. infant: hiv antigen is detected by pcr on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant. exclusion criteria: * subject cannot provide legal independent informed consent.

Keywords: prevention of mother-infant hiv transmission